Self-retaining wound closure device including an anchoring loop

ABSTRACT

A self-retaining suture includes a plurality of tissue retainers which allow deployment in a deployment direction, but prevent movement in the opposite direction. The self-retaining suture has a needle at the proximal end and a tissue anchor at the distal end. The tissue anchor includes a curved portion of the suture formed into a loop which anchors the suture in the tissue. Additionally, the suture can be passed through a tissue and then passed through the loop to secure the distal end of the suture to the tissue.

CLAIM TO PRIORITY

This application is a continuation of U.S. application Ser. No.10/908,539, filed May 16, 2005, now pending; which claims the benefitunder 35 U.S.C. 119(e) of U.S. Provisional Application No. 60/521,528,filed May 14, 2004, which applications are incorporated herein byreference in their entireties.

BACKGROUND OF THE INVENTION

The present invention relates generally to methods and devices forjoining or positioning bodily tissue in surgical applications and woundrepair, and more particularly to a surgical suturing method and devicesfor joining or positioning bodily tissue using a suture having aplurality of barbs that permit the suture to be pulled through thetissue in one direction but resist movement of the suture relative tothe tissue in the opposite direction.

Single-directional barbed sutures have a plurality of barbs that permitthe suture to be pulled through tissue in one direction, but resistmovement of the suture in the tissue in the opposite direction. Suchsutures may have one end that is pointed to allow penetration andpassage through tissue in the one direction and another end that is ananchor which engages the tissue at the initial insertion point toprevent further movement in the one direction. Bi-directional barbedsutures may have barbs extending in one direction at one end andopposing barbs at the other end, preventing movement of the suturethrough tissue in either direction between two pointed ends.

Methods for placement of barbed sutures in tissue include, but are notlimited to, straight, zigzag, and curvilinear patterns such as alpha,sinusoidal, and corkscrew. In general such patterns terminate in analignment coincident with the pattern, meaning, for example, that astraight pattern terminates along a straight path, a sinusoidal patternterminates along a sinusoidal path, and so forth.

Barbed sutures may be used to approximate tissue adjacent to a wound ora tissue separation, or to position and support tissue where there is nowound in procedures such as cosmetic surgery.

SUMMARY OF THE INVENTION

According to the present invention a barbed suture is provided includingan elongated body, one pointed end, a plurality of barbs extending fromthe periphery of the body, and one end having an anchor. The barbspermit movement of the suture through the tissue in the direction ofmovement of the pointed end and prevent movement of the suture in adirection opposite the direction of movement of the pointed end. Theanchor includes at least one arcuate limb extending outside theperiphery of the body to a greater degree than the barbs, and preventsmovement of the suture in the direction of movement of the pointed end.A variety of anchor designs are provided, including but not limited toanchors with arcuate limbs evenly or unevenly spaced around the body andwith equal or differing lengths, with or without segments attached. Theanchors may, for example, collapse, have a hook shape, clip shape, “T”shape with segments mounted to the “T”, a harpoon end, a loop end,hemispherical shape, coneflower shape, or the shape of an “M”.

Also according to the present invention is a method of placing a barbedsuture in bodily tissue. The suture includes at least one pointed endand a central portion having barbs that allow movement of the suture inthe direction of movement of the pointed end and resist movement of thesuture away from the direction of movement of the pointed end. Themethod includes inserting the pointed end of the suture in the tissue,and then advancing the suture through the tissue such that the centralportion is disposed along a first path. The suture deviates from thefirst path proximate to the at least one pointed end of the suture alonga second path, and the second path forms an angle with the projectedfirst path, had the suture remained on the first path, of at leastapproximately 30 degrees.

Further according to the present invention, a method of placing a barbedsuture in bodily tissue to approximate tissue on each side of a wound isprovided. The suture includes at least one pointed end and a centralportion having barbs that allow movement of the suture in the directionof movement of the pointed end and resist movement of the suture awayfrom the direction of movement of the pointed end. The method includesinserting the pointed end of the suture in the tissue and then advancingthe suture through the tissue along a first path. Then the suturedeviates from the first path to follow a second path generally disposedlaterally away from the wound. The suture further deviates from thesecond path proximate to the at least one pointed end of the suturealong a third path, and the third path forms an angle with the projectedsecond path, had the suture remained on the second path, of at leastapproximately 30 degrees.

Yet further in accordance with the present invention, a method ofplacing a single-directional barbed suture in bodily tissue toapproximate a wound is provided. The suture includes an elongated body,one pointed end, one end terminating in an anchor, and a plurality ofbarbs extending from the periphery of the body. The anchor extendsoutside the periphery of the body to a greater degree than the barbs.The barbs permit movement of the suture through the tissue in thedirection of movement of the pointed end and prevent movement of thesuture in a direction opposite the direction of movement of the pointedend. The anchor prevents movement of the suture in the direction ofmovement of the pointed end. The method includes inserting the pointedend of the suture into one face of the wound and advancing the suturethrough the tissue until the anchor achieves adequate holding strengthin the tissue to resist further movement in the tissue, leaving theanchor embedded in the tissue.

Also in accordance with the present invention, a method of placing asingle-directional suture in tissue using an insertion device isprovided. The suture includes an elongated body, one pointed end, oneend terminating in an anchor, and a plurality of barbs extending fromthe periphery of the body. The anchor, when extended, extends outsidethe periphery of the body to a greater degree than the barbs. The barbspermit movement of the suture through the tissue in the direction ofmovement of the pointed end and prevent movement of the suture in adirection opposite the direction of movement of the pointed end. Theanchor prevents movement of the suture in the direction of movement ofthe pointed end. The insertion device includes a tubular element inwhich the suture body is at least in part initially disposed and havingleading and trailing ends with openings therein with the pointed end ofthe suture proximate to the leading end. The method includes insertingthe pointed end of the suture and the leading end of the insertiondevice into the tissue at an insertion point. The pointed end of thesuture and the leading end of the insertion device are pushed throughthe tissue until reaching an endpoint. The insertion device is grippedand pulled at the trailing end to remove the insertion device. Tissue ismanually grouped and advanced along the suture as desired.

Also according to the present invention another method of placing asingle-directional suture in tissue using an insertion device isprovided. The suture includes an elongated body, one pointed end, oneend terminating in an anchor, and a plurality of barbs extending fromthe periphery of the body. The anchor, when extended, extends outsidethe periphery of the body to a greater degree than the barbs. The barbspermit movement of the suture through the tissue in the direction ofmovement of the pointed end and prevent movement of the suture in adirection opposite the direction of movement of the pointed end. Theanchor prevents movement of the suture in the direction of movement ofthe pointed end. The insertion device includes a tubular element havingleading and trailing ends. The method includes inserting the leading endof the insertion device at an insertion point and through the tissueuntil reaching an endpoint and inserting a leading end of the sutureinto the insertion device at least until the trailing end of the sutureis within the insertion device. A plunger is inserted into the trailingend of the insertion device to abut the trailing end of the suture. Theplunger is depressed to push the leading end of the suture out of theinsertion device. The insertion device is gripped and pulled at thetrailing end to remove the insertion device, leaving the suture inplace. The tissue is manually grouped and advanced along the body of thesuture as desired.

Also in accordance with the present invention, a method of performing asurgical procedure using a bi-directional barbed suture is provided. Thebarbed suture includes an elongated body, first and second sharp pointeddistal ends for penetrating tissue, and a plurality of barbs extendingfrom the periphery of the body. The barbs on a first portion of the bodybetween the first end of the suture and a first axial location on thebody permit movement of the suture through the tissue in a direction ofmovement of the first end and prevent movement of the suture relative tothe tissue in a direction opposite the direction of movement of thefirst end. The barbs on a second portion of the body between the secondend of the suture and a second axial location on the body which is lessthan the distance from the second end to the first axial location permitmovement of the suture through the tissue in a direction of movement ofthe second end and prevent movement of the suture relative to the tissuein a direction opposite the direction of movement of the second end. Aninsertion device is used and includes a tubular element and leading andtrailing ends. The method includes inserting the leading end of theinsertion device at an insertion point in the tissue, and then advancingthe leading end of the insertion device through tissue until reaching aselected point. The first pointed end of the suture is inserted into theinsertion device at least until one barb extends out of the insertiondevice. The insertion device is gripped and pulled at the trailing endto remove the insertion device, leaving the full length of the suture inplace in the tissue. Tissue is manually grouped and advanced along thebody of the suture as desired.

Also in accordance with the present invention is another method ofperforming a surgical procedure using a bi-directional barbed suture.The barbed suture includes an elongated body, first and second sharppointed distal ends for penetrating tissue, and a plurality of barbsextending from the periphery of the body. The barbs on a first portionof the body between the first end of the suture and a first axiallocation on the body permit movement of the suture through the tissue ina direction of movement of the first end and prevent movement of thesuture relative to the tissue in a direction opposite the direction ofmovement of the first end. The barbs on a second portion of the bodybetween the second end of the suture and a second axial location on thebody which is less than the distance from the second end to the firstaxial location permit movement of the suture through the tissue in adirection of movement of the second end and prevent movement of thesuture relative to the tissue in a direction opposite the direction ofmovement of the second end. The method includes inserting the first endof the suture into tissue at an insertion point and then advancing thesuture in a generally curvilinear path until the second axial locationis at the point of insertion of the first end of the suture and thefirst end of the suture exits the tissue at an exit point, leaving alength of the first portion of the suture in the tissue. The second endof the suture is inserted into tissue at the insertion point of thefirst end of the suture. The suture is advanced in a generallycurvilinear path distally from the first portion of the suture, untilthe second end of the suture exits the tissue at an exit point, leavinga length of the second portion of the suture in the tissue. The tissueis manually grouped along the body of the suture as desired. Theamplitude of each curvilinear path is generally perpendicular to theresultant holding force exerted by the suture on the tissue.

Also according to the present invention, a method of placing a firstsingle-directional barbed suture and a second single-directional barbedsuture in bodily tissue is provided. The sutures each include anelongated body, one pointed end, and one trailing end, and a pluralityof barbs extending from the periphery of the body. The barbs permitmovement of the suture through the tissue in the direction of movementof the pointed end and prevent movement of the suture in a directionopposite the direction of movement of the pointed end. The methodincludes inserting the first end of the first suture into tissue at aninsertion point and then advancing the suture in a generally curvilinearpath until the pointed end of the first suture exits the tissue at anexit point, leaving a length of the body of the first suture in thetissue. The pointed end of the second suture is inserted into tissue atthe insertion point of the first suture, and the second suture isadvanced in a generally curvilinear path until the pointed end of thesecond suture exits the tissue at an exit point, leaving a length of thebody of the second suture in the tissue. The first and second suturesare tied together at the insertion point. Tissue is manually grouped andadvanced along the body of each suture as desired. The amplitude of eachcurvilinear path is generally perpendicular to the resultant holdingforce exerted by each suture on the tissue.

Further according to the present invention, another method of placing asingle-directional barbed suture in bodily tissue is provided. Thesuture includes an elongated body, one pointed end, one end terminatingin an anchor, and a plurality of barbs extending from the periphery ofthe body. The anchor extends outside the periphery of the body to agreater degree than the barbs. The barbs permit movement of the suturethrough the tissue in the direction of movement of the pointed end andprevent movement of the suture in a direction opposite the direction ofmovement of the pointed end, while the anchor prevents movement of thesuture in the direction of movement of the pointed end. The methodincludes making an incision in the tissue to define a face of thetissue, and inserting the pointed end of the suture in the face of thetissue. The pointed end of the suture is advanced through the tissue toan exit point. The anchor is placed in the incision. The pointed end ofthe suture is advanced through the tissue until the anchor achievesadequate holding strength in the tissue to resist further movement inthe tissue, leaving the anchor embedded in the tissue.

Yet further according to the present invention, a method for joining twoends of severed internal tissue to allow tissue healing and regrowthtogether of the two ends of the internal tissue in vivo using asingle-directional barbed suture is provided. The suture includes anelongated body, one pointed end, one end terminating in an anchor, and aplurality of barbs extending from the periphery of the body. The anchorextends outside the periphery of the body to a greater degree than thebarbs. The barbs permit movement of the suture through the tissue in thedirection of movement of the pointed end and prevent movement of thesuture in a direction opposite the direction of movement of the pointedend, while the anchor prevents movement of the suture in the directionof movement of the pointed end. The method includes inserting thepointed end of the suture into a first end of the internal tissue andpushing the pointed end through the internal tissue along a curvilinearpath, proceeding away from the first end and farther into the tissue.The pointed end of the suture is gripped and pulled out of the internaltissue to draw the anchor proximate to the first end of the tissue. Thepointed end of the suture is pushed along the periphery of the internaltissue adjacent the exit point. The pointed end is pushed along thecurvilinear path and then returns along the path to the first end, andexiting from the first end of the tissue. The pointed end is insertedinto an opposing, second end of tissue, and is pushed along acurvilinear path, proceeding away from the second end and farther intothe tissue, then returning to the second end, and exiting from thesecond end of the tissue. The pointed end is inserted into the first endof tissue, pushing the pointed end along a curvilinear path, proceedingaway from the second end and farther into the tissue, then returningtoward the first end and exiting the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, referenceshould now be had to the embodiments shown in the accompanying drawingsand described below. In the drawings:

FIG. 1 is a perspective view of an embodiment of a barbed suture with ananchor for use according to the methods of the present invention.

FIGS. 2-11 are end views of embodiments of barbed sutures with anchorsaccording to the present invention.

FIGS. 12-20 are elevation views of embodiments of barbed sutures withanchors according to the present invention.

FIG. 21 is an elevation view of a conventional means for affixing asuture to an attachment.

FIGS. 22 and 23 are elevation views of means for affixing sutures toanchors in accordance with the present invention.

FIGS. 24 and 25 are elevation views of a suture having a looped endaccording to the present invention.

FIGS. 26 and 27 are plan views of embodiments of methods according tothe present invention for joining two sides of an open wound in tissue.

FIGS. 28 and 29 are plan views of embodiments of methods according tothe present invention for joining two sides of an open wound in tissue.

FIGS. 30 and 31 are plan views of embodiments of methods according tothe present invention for inverting a surface wound in tissue.

FIGS. 32-39B are plan views of additional embodiments of methodsaccording to the present invention for joining two sides of an openwound in tissue.

FIGS. 40 and 41 are plan views of conventional methods for positioningtissue.

FIGS. 42-45 are plan views of embodiments of methods according to thepresent invention for positioning tissue relative to a barbed suturedisposed in the tissue.

FIGS. 46-48 are section views of embodiments of methods according to thepresent invention.

FIGS. 49 and 50 are plan views of further embodiments of methodsaccording to the present invention for positioning tissue along a barbedsuture disposed in the tissue.

FIGS. 51A-51C are plan views of an embodiment according to the presentinvention for joining two ends of a severed tendon.

FIGS. 52-55 are plan views of embodiments according to the presentinvention for joining two bodily tube ends.

FIG. 56 is a detail view of an embodiment according to the presentinvention of a barb configuration.

FIG. 57 is a plan view of an example performed according to the presentinvention for joining two sides of an open wound in tissue.

FIG. 58 is a plan view of an example performed according to aconventional method for joining two sides of an open wound in tissue.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein, the term “wound” means a surgical incision, cut,laceration, severed tissue or accidental wound in human skin or otherbodily tissue, or other condition where suturing, stapling, or the useof another tissue connecting device might be required.

As used herein, the term “tissue” includes tissues such as skin, bone,muscle, organs, and other soft tissue such as tendons, ligaments andmuscle.

Certain other terminology is used herein for convenience only and is notto be taken as a limitation on the invention. For example, words such as“upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “inward,”“outward,” “upward,” and “downward” merely describe the configurationshown in the figures. It is understood that the components may beoriented in any direction and the terminology, therefore, should beunderstood as encompassing such variations unless specified otherwise.

Barbed sutures and placement methods suitable for use according to themethods of the present invention are described in U.S. Pat. No.5,342,376, entitled “Inserting Device for a Barbed Tissue Connector”,U.S. Pat. No. 5,931,855, entitled “Surgical Methods Using One-WaySuture”, U.S. Pat. No. 6,241,747, entitled “Barbed Bodily TissueConnector”, U.S. Pat. No. 6,599,310, entitled “Suture Method”, U.S.patent application Ser. No. 10/065,256, entitled “Suture Method”, U.S.patent application Ser. No. 10/065,278, entitled “Barbed Suture inCombination with Surgical Needle”, U.S. patent application Ser. No.10/065,279, entitled “Barb Configurations for Barbed Sutures”, and U.S.patent application Ser. No. 10/065,280, entitled “Barbed Sutures”. Thecontents of U.S. Pat. No. 5,342,376, U.S. Pat. No. 5,931,855, U.S. Pat.No. 6,241,747, U.S. Pat. No. 6,599,310, U.S. patent application Ser. No.10/065,256, U.S. patent application Ser. No. 10/065,278, U.S. patentapplication Ser. No. 10/065,279, and U.S. patent application Ser. No.10/065,280 are hereby incorporated by reference.

Referring now to the drawings, wherein like numerals designatecorresponding or similar elements throughout the several views, FIG. 1is a perspective view of a single-directional barbed suture 90 having asuture body 92 with barbs 94 extending from around the peripherythereof, a pointed end 96, and an anchor 98 at the other end. The anchor98 comprises a bar which extends radially outwardly of the suture body92 in a plane substantially perpendicular to the longitudinal axis ofthe suture body 92, which generally gives the barbed suture 90 a “T”shape. Many other shapes and configurations of anchors are feasible, asshown in the embodiments in end view (with the suture body normal to andinto the page) in FIGS. 2-11. Each of the anchors shown in FIGS. 2-11have limbs which extend radially outwardly from the suture body 92 agreater distance than the barbs 94. The anchors 98 on the barbed sutures100, 102, 104, 106 depicted in FIGS. 2-5, respectively, have one or aplurality of limbs 108 generally evenly spaced around the periphery atthe end of the suture. The embodiments of the barbed sutures 110, 112,114 shown in FIGS. 6-8 have anchors 98 including a plurality of limbs108 which extend from only a portion of the periphery at the end of thesuture body 92. FIGS. 9-11 show embodiments of the barbed sutures 116,118, 120 wherein each of the respective limbs 122-123, 124-126, 127-130are of different lengths.

FIGS. 12-20 are further embodiments of barbed sutures at one end. FIG.12 shows a barbed suture 132 that has an anchor 134 having limbs 136that are concave toward the other end of the suture. FIG. 13 shows abarbed suture 138 with an anchor 140 having limbs 142 that are concaveaway from the pointed end of the suture. FIG. 14 shows a barbed suture144 with an anchor 146 as shown in FIG. 1, further including a pluralityof segments 148 extending from the bar toward the other end of thesuture. FIG. 15 shows a barbed suture 150 having a hemispherical anchor152. FIG. 16 shows a barbed suture 154 having an anchor 156 thatresembles a coneflower. FIG. 17 shows a barbed suture 158 having ananchor 160 formed by a loop of the body 92 that crosses itself to form aclip, wherein tissue may be received between the clip. FIG. 18 shows abarbed suture 162 having an anchor 164 formed by a hook of the suturebody 92. FIG. 19 shows a barbed suture 166 having an anchor resemblingan “M” wherein the body 92 of the suture extends from the middle leg ofthe “M”. FIG. 20 shows a barbed suture 170 having a single barb 172,larger than the opposing barbs 94, extending towards the other end ofthe suture 170. As demonstrated by the variety of anchor designs ofFIGS. 12-20, many anchor designs are possible for use with the barbedsuture and within the scope of the present invention.

The anchors shown in FIGS. 1-20 may be integrally formed with the body92 of the barbed suture or, alternatively, may be mounted to the end ofthe suture. FIGS. 21-23 demonstrate ways that the anchors may be affixedto the barbed sutures. FIG. 21 shows the anchor 172 of FIG. 20. The endof the anchor 172 has an axial bore 178. Teeth 176 are provided on theinside of the bore 178 and angled inwardly. The suture body 92 isinserted into the bore 178 and the end of the anchor 172 is crimpedaround the suture body 92. FIG. 22 shows the anchor 172 including aplurality of spaced rings 182 on the end of the suture body 92. The endof the suture body 92 is inserted through the rings 182. Barbs 184 areprovided on the suture body 92 that oppose the rings 182 and secure thesuture body 92 in place by engaging the rings 182. FIG. 23 shows aconnection 186 between the anchor 188 and barbed suture body 92 madewith, for example, glue or heat.

FIG. 24 shows a suture 190 having a loop 192 at one end. Referring toFIG. 25, the suture 190 is placed in tissue 194 by passing the suture190 through tissue 194 and then through the loop 192. Tissue 194 istrapped by the suture 190 and the loop 192 resulting in the suture 190being anchored.

The anchors according to the present invention may be formed by stampingand drilling, injection molding, or a laser cutting system, or othermethod as selected by one of ordinary skill in the art. The anchors maybe made of bio-absorbable material, or a material as selected by one ofordinary skill in the art.

Various bio-absorbable polymers include, but are not limited to,polydioxanone, polylactide, polyglycolide, polycaprolactone, andcopolymers thereof. Commercially available examples are polydioxanone(sold as PDS II, a trade name used by Ethicon for selling surgicalsutures), copolymer of about 67% glycolide and about 33% trimethylenecarbonate (sold as MAXON®, a trademark registered to American Cyanamidfor surgical sutures), and copolymer of about 75% glycolide and about25% caprolactone (sold as MONOCRYL®, a trademark registered to Johnson &Johnson for sutures and suture needles). Barbed sutures made from suchbio-absorbable materials are useful in a wide range of applications.

Additionally, anchors may be formed from a non-absorbable material,which may be a polymer. Such polymers include, but are not limited to,polypropylene, polyamide (also known as nylon), polyester (such aspolyethylene terephthlate), polytetrafluoroethylene (such as expandedpolytetrafluoroethylene, sold by Gore as GOR-TEX®), polyether-ester(such as polybutester, which is the condensation polymerization ofdimethyl terephthlate, polytetramethylene ether glycol, polymers havingester units (such as polyglycolide), and 1,4-butanediol, and which ismarketed by Davis & Geck and by U.S. Surgical, companies owned by Tyco,under the name NOVAFIL®, which is a trademark registered to AmericanCyanamid for surgical sutures), or polyurethane Alternatively, thenon-absorbable material may be metal (e.g., steel), metal alloys,natural fiber (e.g., silk, cotton, et cetera), and the like.

As used herein, the term wound means a surgical incision, cut,laceration, severed tissue, or accidental wound in human skin or otherbodily tissue, or other condition where suturing, stapling or the use ofanother tissue connecting device might be required.

FIGS. 26-39B show a variety of methods of suture placement in tissue forapproximating the sides of wounds or separated tissue according toseveral embodiments of the present invention. The methods of sutureplacement include one or more terminal J-stitches, S-stitches, or thelike. A terminal J-stitch, S-stitch, or the like comprises a sutureplacement method wherein a portion of the end of the suture extends in adifferent direction relative to the adjacent portion of the suture. Therelative direction of the end portion of the suture may be, for example,at least approximately 30 degrees from the projected path of theadjacent portion of the suture. For convenience herein, reference ismade to J-stitches and S-stitches, but it is understood that sutureplacement may differ from J-stitches or S-stitches yet still be withinthe scope of the present invention. Placement of the suture according tothe methods of the present invention may be done either by needles orinsertion devices as discussed below. Placement in such patterns may befacilitated by manipulation of tissue in addition to or in place ofmanipulation of the sharp pointed end of the suture. Tissue may bemanually grouped and advanced along the suture in accordance with thepresent invention as described and shown herein.

Reference is sometimes made herein to pointed ends of a suture. Thepointed ends of the suture may be straight or curved. In one embodiment,the pointed ends of the suture may be surgical needles secured at eachend of the body of the suture so that the body extends between the shankends of the two needles. The needles are preferably constructed ofstainless steel or other surgical grade metal alloy. The needles may besecured to the suture body by means of adhesives, crimping, swaging, orthe like, or the joint may be formed by heat shrinkable tubing. Adetachable connection may also be employed such that the needles may beremoved from the body of the suture by a sharp tug or pull or bycutting. The length of the needles is selected to serve the type oftissue being repaired so that the needles can be completely removedleaving the suture body in the desired position within the tissue.

In FIG. 26, the sides of a wound 250 in tissue 252 are approximatedusing two bi-directional barbed sutures 254, 256 having barbs 94.Throughout the figures, solid line sutures indicate the sutures arevisible, dashed line sutures indicate the sutures are embedded intissue, and dotted line sutures indicate an alternative embeddedlocation for the suture. A first suture 254 is positioned using a suturemethod wherein the two ends are placed in the tissue using a terminalJ-stitch 260, 262. A second suture 256 is positioned in the tissue usinga suture method wherein the two ends are placed in the tissue using aterminal S-stitch 264, 266. The J-stitches 260, 262 and S-stitches 264,266 are shown to be pointing in the direction of the other suture, or“inward,” but could also be pointed outward in the alternative locations260 a, 262 a, 264 a, 266 a depending on the application and preferenceof one of ordinary skill in the art. As an example showing the placementof a J-stitch, the end portion of the J-stitch 262 of the first suture254, aligned along A, is positioned at angle θ from the projected pathof the adjacent portion of the suture 254 B, and is shown to be about 90degrees. As an example showing the placement of an S-stitch, the endportion of the S-stitch 266 of the second suture 256, aligned along C,is positioned at angle a from the projected path D of the adjacentportion of the suture 256, and is shown to be about 45 degrees. TheJ-stitch and S-stitch angles H and a may be greater or less than shownand the suture is still considered to be in accordance with the presentinvention.

FIG. 27 shows single-directional barbed sutures 270, 272 approximatingthe sides of a wound 250. Each suture 270, 272 has an anchor 274, 276and is placed in the tissue 252 using a method which ends with aterminal J-stitch 278 or S-stitch 280 at the opposite end. AlternativeJ-stitch or S-stitch positions 278 a, 280 a may be used. Anchors may beembedded in the tissue 252 as with the anchor 274 of a first suture 270by making a small incision, or may be above the tissue as with theanchor 276 of a second suture 272. The sutures 270, 272 may be placedwith a sharp pointed end such as a needle at the opposite, leading endof the suture from the anchors 274, 276. The anchors 274, 276 are shownschematically; it is understood that a variety of anchors is availableas appropriate, as previously discussed.

For convenience in the remaining embodiments described herein, mostlyJ-stitches are shown. It should be understood, however, that in allembodiments shown herein that have a suture placed with a needle,S-stitches could replace any depicted J-stitches. In one method ofgrouping and advancing tissue along the suture body, the sharp pointedend of the suture exits the tissue prior to completing, for example, theJ-stitch. Then the tissue is grouped and advanced along the suture body,and then the suture pointed end enters the tissue to complete theJ-stitch.

FIGS. 28 and 29 show suture methods using an alpha stitch pattern usinga bi-directional barbed suture 254 and a single direction suture 270,respectively, to close a wound 250. The suture method using thebi-directional barbed suture 254 of FIG. 29 has a J-stitch at each endthat may be either downward 284, 286, upward 284 a, 286 a, or acombination thereof. The suture method using the single direction sutureof FIG. 29 has a J-stitch shown at its leading end that may be eitherdownward 288 or upward 288 a. A purse-string stitch is a surgical suturemethod used to repair excisions, such as in as appendectomy, whereinverting the remaining tissue is desired. A purse-string stitch may beused according to the methods of the present invention with abi-directional barbed suture 254 or a single direction suture 270 asshown in FIGS. 30 and 31, respectively. The description of FIG. 28applies to FIG. 30, and the description of FIG. 29 applies to FIG. 31.

FIGS. 32 and 33 show suture methods using a zigzag pattern toapproximate the sides of a wound 250 with a bi-directional barbed suture254 and a single-directional barbed suture 270 with an anchor 274,respectively. As previously shown in FIG. 26 and as shown in FIG. 32,the terminal end path A of the end portion of the suture 254 in theJ-stitch 262 is at an angle from the projected suture path B of theadjacent portion of the suture. The J-stitch angle shown is about 135degrees. It is understood that the angle may vary and still beconsidered a J-stitch.

FIGS. 34 and 35 show a suture method for approximating the sides of awound using a bi-directional barbed suture 254 and a single directionbarbed suture 270 with an anchor 274, respectively, placed in the tissue252 in a sinusoidal pattern.

FIGS. 36 and 37 show a bi-directional barbed suture 254 and a singledirection barbed suture 270 with an anchor 274, respectively, placed inthe tissue 252 in a corkscrew pattern.

With respect to the bi-directional suture 254 of FIGS. 32, 34, and 36,the suturing begins at an intermediate point between the ends of thewound and proceeds in both directions. In the zigzag and sinusoidalpatterns of FIGS. 32 and 34, respectively, the central portion of thesuture 254, where the barbs 94 change direction, could also be locatedat one end of the wound, with both ends of the suture proceeding in thesame direction along the wound in separate patterns which are mirrorimages of one another. Both ends of the suture could then have aJ-stitch or S-stitch at the same end of the wound. The J-stitches ofFIGS. 32, 34, and 36 may be inward 260, 262, outward 260 a, 262 a, or acombination thereof. The J-stitches of FIGS. 33, 35, and 37 may beinward 278 or outward 278 a. Further, the suture 270 shown in FIGS. 33and 35 could double back in a mirror image pattern to the end of thewound placing the leading end near the anchor 274, and could have aJ-stitch or S-stitch at that location.

The anchors 274 of FIGS. 33, 35, and 37 are shown as contacting thesurface of the tissue 252. Another method according to the presentinvention allows placement of the anchor 274 below the surface of thetissue as shown in FIGS. 38A and 38B.

As shown in FIG. 38A, a sharp pointed end of the suture 270, forexample, a needle 280, is at the leading end of a single-directionalbarbed suture 270 and is inserted into a face 288 of a wound 250. As thesuture 270 is pulled through the tissue by the needle 280, the anchor274 will abut the face of the wound 288. As the suture is pulled toapproximate the wound, the anchor 274 will move until it meetsresistance in the tissue 252. The tissue 252 generally comprises layersthat are parallel to the surface of the tissue. Depending on the shapeof the anchor 274, the anchor 274 may be expected to move between thelayers and past the face 288 of the wound 250, embedding into theadjacent tissue, arriving in a position spaced from the face 288 of thewound 250 as shown in FIG. 38B. Referring to FIG. 38A, in oneembodiment, as selected by one of ordinary skill in the art the distanceE from the end of the wound to the anchor 74 may be approximately thesame as the distance between “bites,” or the distance F from the face288 of the wound to the peak 291 of the pattern.

Another suture method using a single directional barbed suture whereinanchors are embedded in tissue is used for approximating a small wound,as shown in FIGS. 39A and 39B. In FIG. 39A, the needle 280 at theleading end of a single-directional barbed suture 270 is inserted intothe face 288 of a wound 250. Similarly to the method shown in FIGS. 38Aand 38B, as the suture 270 is pulled by the needle 280, the anchor 274will abut the face 288 of the wound 250. As the suture is pulled toapproximate the sides of the wound 250, the anchor will move into thetissue 252 until it meets resistance in the tissue 252. In FIG. 39B, theanchor is shown to have moved into final position spaced from the woundface 288. The placement of the suture 270 may form a loop, and theleading end may be placed as a J-stitch with alternative configurations278, 278 a.

FIGS. 40-50 show suture method according to the present inventionwherein barbed sutures are placed to position tissue where there is nowound and the sutures are below the surface of the tissue, such as incosmetic surgery. FIGS. 40 and 41 show the placement conventional,non-barbed sutures in tissue for providing lift. The method of FIG. 40uses one suture 300 with one knot 302 at the top and an exit/entry point304 at the bottom. The knot is tightened to adjust the tissue 252 to thedesired amount of lift. The method of FIG. 41 uses two sutures 306, 308with one knot 310 at the top and another knot 312 at the bottom. Theknots are tightened to provide the desired amount of lift to the tissue252. The force sufficient to provide tissue lift is applied at the knots302, 310, 312, and the load on the tissue 252 is concentrated at the topknots 302, 310 and bottom knot 312 or low point 304 of the sutures.

FIG. 42 shows a suture method according to the present invention whereinbi-directional barbed sutures 254, 256 are placed substantially parallelto one another and having J-stitches 260, 262, 264, 266 at each end thatare directed toward the adjacent suture, or inward. FIG. 43 shows asimilar suture method using two parallel bi-directional barbed sutures254, 256 with the J-stitches 260 a, 262 a, 264 a, 266 a directedoutwardly. FIG. 44 shows a bi-directional barbed suture 254 withterminal J-stitches 314, 316 extending in opposite directions. Once thesutures 254, 256 are placed, the tissue may be manually advanced alongeach suture to be grouped as desired by the surgeon for a certain amountof tissue lift. Unlike the conventional methods of FIGS. 40 and 41, theresistance provided by the barbed sutures is distributed along thelength of the suture.

FIG. 45 shows an embedded single-directional barbed suture 270 having ananchor 274 and a pointed end 320 positioned below the surface of thetissue 252 and terminating in a J-stitch 278. Optionally the J-stitch278 may be oriented differently or omitted altogether.

One method of placing a single-directional barbed suture 270 below thesurface of tissue 252 is with an insertion device. Insertion devicedesigns include straight, curved, and corkscrew. One such method ofusing an insertion device 322 is shown in FIG. 46. The insertion device322 may include a straight or curved tube 324, a leading end 326, atrailing end 328, and a handle 330 for ease of use. Some nonlinearsuture installations may be performed with a straight tube bymanipulation of tissue rather than with a curved tube. The pointed end320 of the suture 270 may extend from the leading end 326 of theinsertion device 322 or from an opening (not shown) in the side of theinsertion device 322. At least one barb 94 on the suture 270 must extendthrough the opening at the leading end 326 or through the opening at theside of the insertion device. Alternatively, an anchor 274 could extendthrough the opening at the leading end 326 or through the opening at theside of the insertion device. The insertion device 322 is advancedthrough the epidermis 332 and into subcutaneous tissue 334. When in thedesired position, the insertion device 322 is withdrawn by the trailingend 328, and the pointed end 320 and barbs 94 of the suture 270 engagein the subcutaneous tissue 334, leaving the suture 270 in place torestrict movement in one direction as shown in FIG. 48. The anchor 274is also embedded, restricting movement in the other direction.

Another method of placing a single-directional barbed suture 270 with aninsertion device is shown in FIG. 48. The insertion device 340 has astraight or curved tube 342, a leading end 344, a trailing end 346, anda reciprocating plunger 348. The anchor 274 is disposed in the tube 342adjacent the leading end 344 of the insertion device 340. The insertiondevice 340 is advanced through the epidermis 330 and into thesubcutaneous tissue 334. When in the desired position, the plunger 348is depressed until the anchor 274 is expelled from the tube 342 and intothe subcutaneous tissue 334. As the insertion device 340 is withdrawnfrom the trailing end 346, the anchor 274 engages in the tissue torestrict movement in one direction. The barbs 94 also engage of thesubcutaneous tissue 334, restricting movement in the opposite direction.

The anchor 274 may be any design that fits within the insertion device,and may include collapsing designs that are collapsed while within theinsertion device tube and expand when released. A “T” shape design isshown in the figures for convenience, and may be used when configured tofold along the direction of the insertion device tube. Further, themethods illustrated in FIGS. 45-48 and described above may also be usedto place single-directional barbed sutures with an insertion device toapproximate the sides of a wound, as shown in FIG. 27.

FIG. 49 shows placement of five bi-directional barbed sutures 380,400-403 using methods for cosmetic lifts for the brow, face, and neckaccording to the present invention. Each of the five bi-directionalbarbed sutures 380, 400-403 shown may be placed, in one embodiment,using a straight needle at each end. For a brow lift, the ends of thesuture 380 forming an inverted “U” or “V” shape, or variations thereof,enter at the same insertion point 382, generally superior to thehairline (or where the hairline would be expected). Sutures 400-403 maybe placed with the ends extending in generally opposite directionsstarting from an insertion point 404-407 that may generally be superiorto the expected hairline and exiting distally. In all methods, aside-to-side motion with the needle is used, in one embodiment withoutexiting the tissue until terminating, for placing the suture in asinusoidal pattern. The sinusoidal pattern may have greater or lesseramplitudes and frequencies than those shown in FIG. 49 and be within thescope of the present invention. As an alternative to bi-directionalbarbed sutures 380, 400-403, single-directional barbed sutures could beused for each portion 384, 386, 408, 410-416 of the respective suturesand their ends tied at the insertion points 382, 404-407 to the adjacentsuture. Further, there may be generally straight portions of placedsuture between the curvilinear portions and exit points. Followingplacement of a suture, tissue is advanced and grouped along the body ofthe suture for providing lift and tissue support.

Placement of a suture in a sinusoidal pattern increases the suture's“shock-absorbing” capability and provides multiple opportunities for thesuture to elongate or straighten and prevent shifted or repositionedtissue from relapsing (moving toward its original position). Theamplitude of the curvilinear pattern is generally perpendicular to thedirection of the resultant holding force of the suture, which isgenerally along the axis of the curvilinear pattern. An exampleamplitude is shown at G in FIG. 49 and an example resultant holdingforce is shown at H. Pulling of the tissue may cause the tissue torelapse more than with straight-placed sutures, but there may be lessbreakage of the sinusoidally placed sutures because of the flexureprovided by the sinusoidal pattern. The sinusoidal pattern may permitlarger or tighter lifts as compared to the same number and size ofsutures that are linearly placed. The sinusoidal pattern may also allowthe use of fewer and bigger sutures, which may be desirable when thepatient does not want to be sedated.

For the browlift sutures 380, 400 and other lifts on the forehead, theportion 384, 386, 408 of the suture in the forehead engages just abovemuscle, frontalis, in subepidermal tissue. Subepidermal tissue includesthe papillary dermis, reticular dermis, and subcutaneous tissue. Theportions 410-413 of the sutures 400-403 extending into the scalp engagethe galea aponeurotica and subepidermal tissue.

In general, for the sutures 401-403 in the face and neck, the anteriorportions 414-416 engage just above muscle, platysma, but are slightlymore superficial in the cheek or near the nose, and in subepidermaltissue. In particular, the anterior portion 414 of the facelift suture401 in the upper face extends toward the nasolobial fold 418, engagingthe subepidermal tissue, superficial muscular aponeurotic system, orboth.

Specifically with respect to the facelift suture 402 in the cheek, theinsertion point 406 is approximately at the posterior mandibular angle.The first end 412 of the suture is pushed posterially throughsubepidermal tissue, the superficial aponeurotic system, or combinationsthereof along a path approximately parallel to the mandibular border,exiting distally. The second end 415 of the suture is pushed anteriorlythrough subepidermal tissue, the superficial aponeurotic system, orcombinations thereof along a path approximately parallel to themandibular border, also exiting distally.

For the surgical procedure comprising a neck lift, the insertion point407 of the barbed suture 403 is approximately at the upper sternomastoidmuscle. The first end 413 of the suture is pushed posterially throughsubepidermal tissue, the superficial aponeurotic system, or combinationsthereof along a path approximately parallel to the mandibular border,exiting distally. The second end 416 of the suture is pushed anteriorlythrough subepidermal tissue, the superficial aponeurotic system, orcombinations thereof along a path approximately parallel to themandibular border, also exiting distally.

Additional cosmetic surgery applications may be performed within thescope of the present invention. For example, thigh lifts and breastlifts may be performed. In a thigh lift the insertion point is generallyat the inguinal crease. The first end of the suture is pushed craniallythrough subepidermal tissue until the first end of the suture extendsout of the tissue, and the second end of the suture is pushed caudallythrough subepidermal tissue until the second end of the suture extendsout of the tissue on the thigh. The thigh tissue is then advanced andgrouped along the body of the suture for providing lift and tissuesupport.

In a breast lift, the insertion point is at the upper aspect of thebreast curvature. The first end of the suture is pushed throughsubcutaneous tissue, dermal tissue, and pectoralis muscle untilextending out of the tissue at an exit point on the upper portion of thebreast. The second end of the suture is pushed caudally through fibrousand fatty tissues until the second end of the suture extends out of thetissue at an exit point along the anterior aspect or the lower curvatureof the breast. The breast tissue is then advanced and grouped along thebody of the suture for providing lift and tissue support.

FIG. 50 shows suture methods for cosmetic surgery applications usingsingle-directional barbed sutures 430-435 with anchors 436-441 accordingto the present invention. These suture methods may optionally include aterminal J-stitch or S-stitch (not shown), and may be placed with aninsertion device 322, 340 as shown in FIGS. 46-49 or with a needle. Forexample, one suture 434 along the jaw line is shown as terminating atits pointed end with an S-stitch. Another suture 433 in the upper faceis shown having a curvilinear pattern similar to those of FIG. 49.Although a schematic “T” shape anchor 436-441 is shown, the anchor maybe any design as described herein and selected by the surgeon dependingon the application. The anchors may be embedded either by use of aninsertion device or by making a small incision. Another suture 442 isshown in the forehead and is placed with curves at the ends 444, 445,including a J-stitch proximate to the end 445 at the brow. Applicationsto brow, face, neck, thigh, and breast are similar to and correspond tothose detailed above for bi-directional sutures in similar locationswith respect to the tissue engaged. Following placement of the suture,tissue is advanced and grouped along the body of the suture forproviding lift and tissue support. As a variation to grouping andadvancing the tissue along the suture after completing the desiredpattern, such as a J-stitch, the suture pointed end may exit the tissueprior to completing the J-stitch, then the tissue may be grouped andadvanced, and then the J-stitch may be completed.

FIGS. 51A-51C show the use of a single-directional barbed suture 270 forrepair of two parts of a severed tendon 450, 452, referred to forconvenience as the left part 450 and right part 452. As shown in FIG.51A, the suture enters the end 454 of the left part 450 and follows acurvilinear path to an exit point 456. The anchor 274 abuts the end 454of the left part 450. The suture enters again at a point 458 adjacent tothe exit point 456 and continues to form a loop on the curvilinear pathuntil exiting at point 460 and then entering at point 462. The suturecompletes the loop and exits through the end 454 of the left part 450then passes through the end 464 of the right part 452. As shown in FIG.51B, the suture follows the selected curvilinear path advancing throughthe tendon 252 away from the end 464 by exiting at points 466, 468, 470and entering at points 472, 474, 476, and then returns back to the end464 by exiting the tendon through points 478, 480, 482 and enteringthrough points 484, 486, 488. As shown in FIG. 51C, the suture thenagain enters the end 454 of the left part 450, follows the selectedcurvilinear path exiting the tendon at points 490, 492, 494, 496 andentering at points 498, 500, 502, 504 until making a final exit 506 fromthe periphery of the tendon.

Also according to the present invention, methods are provided forjoining the ends of two portions of a tube, a tubular structure, or ahollow organ within the body using a barbed suture, such as the ends ofa blood vessel in an anastomosis procedure. As used herein, the term“tube” includes but is not limited to, blood vessels, the large andsmall intestine, ducts, and the like. As shown in FIGS. 52-55, the endsof the tube may be first cut at an angle prior to joining for promotinga more effective attachment.

Referring to FIG. 52, a method is shown for joining the ends of a tubeusing a single-directional barbed suture 270 having an anchor 274. Thepointed end 280 of the barbed suture 270, which in the embodiment showncomprises a needle, is inserted through the wall and into the interiorof a first end 550 of the tube. The pointed end of the suture 270 isthen inserted from the interior of the tube through the wall of a secondend 552 of the tube. The suture 270 is pulled through the walls of thetube until the anchor 274 contacts the outer surface of the wall of thefirst end 550 of the tube for drawing the two ends 550, 552 of the tubetogether. The suture 270 is then again inserted through the wall of thefirst end 550 of the tube at a point 554 circumferentially spaced fromthe initial insertion point 556. The steps are repeated for advancingthe suture 270 around the tube. After the last bite, the suture patternmay be completed with a terminal J-stitch or S-stitch.

FIG. 53 shows a method of using a bi-directional barbed suture 254 forjoining the ends 550, 552 of a tube using a similar suture pattern asthe method shown in FIG. 52. Beginning at an initial insertion point558, an end of a first portion 560 of the suture 254 is inserted throughthe wall and into the interior of a first end 552 of the tube. The endof the first portion 560 of the suture 254 is then inserted from theinterior of the tube through the wall of a second end 550 of the tube.The first portion 560 of the suture 254 may be pulled through the wallsof the tube until the opposed barbs on a second portion 562 of thesuture 254 contact the outer surface of the wall of the first end 552 ofthe tube for drawing the two ends 550, 552 of the tube together. The endof the first portion 560 of the suture 254 is inserted through the walland into the interior of the first end 552 of the tube at a point 564circumferentially spaced in a first direction from the initial insertionpoint 558. The end of the second portion 562 of the suture 254 isinserted through the wall and into the interior of the second end 550 ofthe tube at a point 566 circumferentially spaced from the exit point 568of the end of the first portion 560 of the suture 254. The end of thesecond portion 562 of the suture 254 is then inserted from the interiorof the tube through the wall of the first end 552 of the tube at a point570 circumferentially spaced in a second direction from the initialinsertion point 558. These steps are repeated for advancing each end ofthe barbed suture 254 around the tube. After the last bite, the suturepattern may be completed with a terminal J-stitch or S-stitch at eachend.

FIG. 54 shows another method of using a bi-directional barbed suture 254for joining the ends 550, 552 of a bodily tube. Beginning at an initialinsertion point 572, an end of a first portion 560 of the suture 254 isinserted through the wall of a first end 552 of the tube. The end of thefirst portion 560 of the suture 254 is then inserted from the interiorof the tube through the wall of a second end 550 of the tube. The firstportion 560 of the suture 254 may be pulled through the walls of thetube until the opposed barbs on a second portion 562 of the suture 254contact the outer surface of the wall of the first end 552 of the tubefor drawing the two ends 550, 552 of the tube together. The end of thefirst portion 560 of the suture 254 is inserted through the wall andinto the interior of the first end 552 of the tube at a point 574circumferentially spaced in a first direction from the initial insertionpoint 572. The end of the second portion 562 of the suture 254 isinserted through the wall of the first end 552 of the tube at a point576 adjacent the initial insertion point 572 of the first portion 560 ofthe suture 254, which practically functions as the same point ofinsertion. The end of the second portion 562 of the suture 254 is theninserted from the interior of the tube through the wall of the secondend 550 of the tube at a point 578 circumferentially spaced from thefirst exit point 580 of the end of the first portion 560 of the suture254. The end of the second portion 562 of the suture 254 is theninserted through the wall of the first end 552 of the tube at a point582 circumferentially spaced in a second direction from the initialinsertion point 576. These steps are repeated for advancing each end ofthe barbed suture 254 around the tube. After the last bite, the suturepattern may be completed with a terminal J-stitch or S-stitch at eachend. Alternatively, the suture pattern may continue as described untilthe ends of the suture cross one another, as shown in FIG. 55. Even thenthe suture pattern may be completed with a terminal J-stitch orS-stitch, if desired.

In the method for joining the ends of a tube according to the presentinvention, the path of insertion of the end of the suture through thetube may include a longitudinal component as the suture is advancedthrough the tissue of the tube. Using this technique, more of the lengthof the suture is placed in the tissue of the tube, which may result inbetter holding strength. Additionally, effective joining of the ends ofa tube within the body can be achieved using the methods describedherein regardless of where the barbed suture initially enters the tubealong the periphery of the free end.

It is understood that although the methods of joining two ends of abodily tube is shown and described, the present invention is not solimited. In particular, the methods according to the present inventionmay include a procedure wherein a portion of tube is grafted between theends of the original tube. This is a procedure particularly used incoronary artery bypass grafting, or CABG. The grafting procedure issimilar to the methods described herein except that the ends of thegraft are attached to the ends of the tube using the suture methodsdescribed above.

The invention is further illustrated by the following non-limitingexample.

EXAMPLE

Testing was performed comparing the tissue holding capacity of abi-directional barbed suture placed in tissue with a J-stitch at eachend with a conventional knotted suture. Two different barb geometrydesigns (A and B) of a bi-directional barbed suture were fabricated frompolydioxanone (PDO), size 0. Each suture was 7 inches long and included78 barbs, equally divided into two opposing segments, in the middle 3inches. The spirality of Design A was 12.8 degrees, and the spirality ofDesign B was 12.4 degrees. The average straight-pull tensile strength ofeach design was measured using ten samples. Using an Optem Zoommicroscope (made by Thales Optem Inc. of Fairport, N.Y.) with anattached video camera, the barb geometries were characterized by fourdifferent parameters: cut angle (φ); cut depth (D_(c)); calculated cutlength (L_(c)); and the distance between cuts (FIG. 56).

The straight-pull tensile strengths and barbed geometries of the barbsutures were determined to be as shown in Table 1.

TABLE 1 Parameters Design A Design B Tensile strength (lb.) 7.12 ± 0.259.89 ± 0.34 Cut angle, φ (°) 152.3 ± 0.8  162.2 ± 2.2  Cut depth, D_(c)(mm) 0.25 ± 0.01 0.12 ± 0.02 Cut length, L_(c) (mm) 0.54 ± 0.02 0.38 ±0.04 Distance between cuts (mm) 0.82 ± 0.01 0.91 ± 0.04

Referring to FIGS. 57 and 58, a full-thickness, 3-cm incision wascreated in the distal jejunum 530 of a cadaveric pig perpendicular toits length. The jejunal segment measured about 10 cm in outercircumference and 5 mm in thickness. Each wound 538 was excised so thatit was centered on a 4 cm by 15 cm piece of tissue. The wound 538 wasclosed with either a barbed suture 254 including the two Designs A and Bas shown in FIG. 57, or control PDS II (polydioxanone) suture 540 asshown in FIG. 58, all of size 0, using a running “over-and-over”technique. Suture strands, in the serosa 542 and mucosa 544, engaged butdid not perforate the mucosal layer. A knot (5 throws) anchored each endof the control suture, whereas the barbed suture 254 was finished withand without a J-stitch bite through adjacent tissue. Bite size (4 mm),distance between bites (5 mm), and number of crosses of the incision(11) were equivalent in all suture types. Wound edges were cut such thatonly the sutures held the two halves together. Ten sutured tissuespecimens of each suture type were tested on a Test Resources UniversalTester, model 200Q (made by DDL of Eden Prairie, Minn.), with a 250 lb.load cell, a 5 cm gauge length, and a crosshead speed of 5 cm/sec. Eachspecimen was stretched to failure, wherein the sutures tore through thetissue to the wound and the two pieces of tissue separated, and themaximum load was recorded.

The average peak forces required to separate the pig intestinal woundsare shown in Table 2:

TABLE 2 Sutures, size 0 Tissue Holding Capacity (lb.) Barbed PDO, A withterminal J-Stitch 7.64 ± 1.39 Barbed PDO, A without terminal J-Stitch4.53 ± 1.07 Barbed PDO, B with terminal J-Stitch 8.40 ± 1.83 Control PDSII 6.61 ± 2.02

By comparison with the U.S. Pharmacopoeia minimum knot-pull tensilestrength requirement of size 0 absorbable sutures, 8.60 lb., the tensilestrength of barbed PDO Design A, appears inferior. However, the Design Awound holding capacity using a terminal J-stitch compares favorably tothat of the same-size control in the pig intestinal model (p=0.19).Further, Design B with a terminal J-stitch not only exceeds the U.S.Pharmacopoeia requirement, but also demonstrates a trend toward highermechanical performance than the conventional suture. The wound holdingstrength omitting the J-stitches and using Design A was inferior to theholding capacity of Design A with J-stitches. Some of this reduction maybe the result of the shorter length of suture in the tissue withJ-stitches omitted, but it is believed that most of the difference isthe result of omitting the J-stitch configuration.

Although the present invention has been shown and described inconsiderable detail with respect to only a few exemplary embodimentsthereof, it should be understood by those skilled in the art that we donot intend to limit the invention to the embodiments shown and describedsince various modifications, omissions and additions may be made to thedisclosed embodiments without materially departing from the novelteachings and advantages of the invention, particularly in light of theforegoing teachings. For example, the barbed sutures with one or moreJ-stitches and S-stitches and the single-directional sutures withanchors may be used in a wide variety of applications, including but notlimited to Nissen fundoplications, stabilization of bowel structuresduring laparoscopic surgery, appendectomy, Zenker's Diverticulumsurgery, urinary bladder cystostomy, securing a replacement heart valve,securing external devices to tissue, and closing axial wounds in bloodvessels. Accordingly, we intend to cover all such modifications,omission, additions and equivalents as may be included within the spiritand scope of the invention.

1. A wound closure device comprising: a needle; a polymer suturefilament having a first end from which the needle extends, and a secondend; a plurality of cuts made into a first portion of the polymer suturefilament adjacent the first end; the plurality of cuts defining aplurality of tissue engaging elements distributed along the firstportion of the polymer suture filament; said tissue engaging elementsbeing adapted to permit movement of the first portion of the polymersuture filament through tissue towards the first end, and preventmovement of the first portion of the polymer suture filament throughtissue towards the second end; a second portion of the polymer suturefilament adjacent the second end being formed into a loop; and the loophaving diameter such that the tissue engaging elements can pass throughthe loop without engaging the loop.
 2. The wound closure device of claim1, wherein said needle is a metal needle attached to the first end ofthe polymer suture filament.
 3. The wound closure device of claim 1,wherein said second end of the polymer suture filament is attached tothe second portion of the polymer suture filament at a position spacedfrom the second end to form said loop.
 4. The wound closure device ofclaim 1, wherein the second end is joined to the second portion of thepolymer suture filament to form the loop.
 5. The wound closure device ofclaim 1, wherein the first portion of the polymer suture filament lieswithin the loop.
 6. The wound closure device of claim 1, wherein: thesecond portion of the polymer suture filament lies within tissue; andthe first portion of the polymer suture filament lies within the loop;thereby anchoring the second portion of the polymer suture filament tosaid tissue.
 7. The wound closure device of claim 1, wherein said loopis devoid of tissue engaging elements.
 8. The wound closure device ofclaim 1, wherein said second portion of the polymer suture filament isdevoid of tissue engaging elements.
 9. The wound closure device of claim1, wherein said tissue-retainers are distributed at about 120 degreeintervals around said polymer suture filament.
 10. The wound closuredevice of claim 1, wherein said tissue-retainers are evenly distributedat intervals around said polymer suture filament.
 11. The wound closuredevice of claim 1, wherein the polymer suture filament is made of abio-absorbable polymer.
 12. The wound closure device of claim 1, whereinthe polymer suture filament is formed of a copolymer comprisingtrimethylene carbonate.
 13. The wound closure device of claim 1, whereinthe polymer suture filament is formed of a copolymer comprisingglycolide.
 14. The wound closure device of claim 1, wherein the polymersuture filament is formed of a copolymer of gylcolide and trimethylenecarbonate.
 15. The wound closure device of claim 1, wherein the polymersuture filament is formed of a copolymer comprising one or more ofcaprolactone, polydioxanone, and polylactide.
 16. The wound closuredevice of claim 1, wherein the tissue engaging elements are barbs.
 17. Awound closure device comprising: a flexible strand having a firstportion and a second portion; a needle extending from the first portion;a plurality of tissue engaging elements extending from the first portionof the flexible strand, said tissue engaging elements being directedaway from the needle and extended away from said flexible strand;wherein said plurality of tissue engaging elements permit movement ofthe flexible strand through tissue towards the needle and preventsmovement of the flexible strand through tissue in an opposite direction;wherein said second portion of the flexible strand ends in a loop; andwherein said second portion of the flexible strand is positioned withinthe loop.
 18. The wound closure device of claim 17, wherein the secondportion of said flexible strand is connected to itself to form saidloop.
 19. A suture comprising: a first pointed end; an elongated bodyhaving a second end; the first pointed end extending from said elongatedbody; said elongated body including a strand of bio-absorbable polymer;a plurality of tissue engaging elements formed in said elongated bodyand extending from the periphery of the elongated body; said tissueengaging elements configured to permit movement of the elongated bodythrough tissue in a direction of movement of said first pointed end byyielding toward the elongated body and, and said tissue engagingelements configured to prevent movement in a direction opposite thedirection of movement of the first pointed end by engaging tissue;wherein said second end of the elongated body forms an anchor adapted tosecure the second end to tissue; and wherein said anchor has a curvedportion of the elongated body formed into a loop.
 20. The wound closuredevice of claim 19, wherein the tissue engaging elements are barbs.